KORU Medical Systems, Inc. (NASDAQ: KRMD) ("KORU Medical" or
the "Company"), a leading medical technology company focused on
the development, manufacturing, and commercialization of innovative
and easy-to-use subcutaneous drug delivery systems that improve
quality of life for patients, today reported financial results for
the third quarter ended September 30, 2022.
Highlights:
- Year-over-year net sales growth of 28.5% to $7.8 million
(inclusive of $0.3 million backorder clearance), marking the fourth
consecutive quarter of double-digit growth
- Expanded Novel Therapies to 14 total collaborations, including
four new Phase II clinical drug trials, and one drug progressed to
Phase III
- Improved sequential gross margin profile to 55.7% in Q3 2022
from 51.1% in Q2 2022
- Raising 2022 full year revenue guidance to $27.5 to $28.0
million
"The third quarter marks another successful quarter for the
Company with strong revenue growth across each of our businesses,"
said Linda Tharby, KORU Medical's President and CEO. "Delivering on
our strategic objectives remains a primary focus, and the progress
made this quarter is representative of continued solid execution by
the team. We are excited by the momentum in our novel therapies
business with multiple new collaborations this quarter and by the
double digit growth performance in both our domestic and
international core business."
2022 Third Quarter Financial Results
Three Months Ended September
30,
Change from Prior Year
2022
2021
$
%
Net Sales
Domestic Core
$
5,900,042
$
5,076,294
$
823,748
$
16.2%
International Core
1,096,746
747,281
349,465
46.8%
Novel Therapies
763,610
216,969
546,641
251.9%
Total
$
7,760,398
$
6,040,544
$
1,719,854
$
28.5%
Total net sales increased $1.7 million, or 28.5%, for the three
months ended September 30, 2022, as compared with the same period
last year as we saw double digit growth across all businesses.
Domestic core growth was primarily driven by increased volume
attributed to SCIg market growth and label expansions including
prefill syringes. Domestic core included the clearing of $0.3
million in backorders from the second quarter of 2022. Novel
therapies sales grew by 251.9% in the third quarter of 2022 related
to services performed for a non-recurring engineering (NRE)
innovation development agreement for a pharmaceutical customer and
increases in clinical trial product sales to several pharmaceutical
customers. Sales growth in our international core business was
driven by volume growth in several EU markets compared with prior
year.
Gross profit increased $0.8 million or 23.7% in the three months
ended September 30, 2022, compared to the same period in 2021. This
increase in gross profit was driven by volume increase in net sales
of $1.7 million as described above. Gross profit as a percentage of
net sales decreased to 55.7% compared to 57.9% from the third
quarter of 2021. The decline in the gross profit percent was
primarily due to higher manufacturing costs associated with labor
and materials. The growth of the novel therapies business, and
associated NRE service revenue also contributed to the lower gross
margin. Unfavorable product mix was offset by a nominal increase in
average selling prices.
Total operating expenses for the third quarter of 2022 were $5.9
million, compared to $4.8 million for the same period in 2021. The
increase in operating expenses is due to strategic investments in
research and development, and new hires to support business
development, commercialization, quality and regulatory
capabilities.
Net loss for the third quarter of 2022 was $1.2 million, or
$(0.03) per diluted share, compared to a net loss of $1.1 million,
or ($0.02) per diluted share for the same period of 2021. Net loss
included a tax benefit of $0.3 million for the third quarter of
2022.
Cash and cash equivalents were $16.4 million as of September 30,
2022.
Assumptions and Outlook for Full Year 2022
KORU Medical's outlook for full year 2022 reflects numerous
assumptions that could affect its business, based on the
information management has as of this date, which includes
assumptions regarding the continued recovery from the COVID-19
pandemic related to new SCIg patient starts, SCIg market growth
rate in the high single digits, plasma supply, clinical trial
activity and expansion of the novel therapies pipeline,
inflationary impact (including labor and supply price increases),
supply chain and labor shortage impacts, timely receipt of other
receivable credits and planned inventory reductions by year end
2022. Management will discuss its outlook and several of its
assumptions on its third quarter 2022 earnings call.
KORU Medical now expects full year 2022 revenue to be in the
range of $27.5 to $28.0 million (previously $27.0 to $27.5
million).
The Company is confirming to exit the year with a 55.0% to 60.0%
gross margin.
The Company is lowering its operating expenses guidance to $26.5
to $27.0 million (previously $27.0 to $28.0 million).
The Company is confirming its guidance to include a minimum cash
balance of $16.0 million for year end 2022.
Conference Call and Webcast Details
The Company will host a live conference call and webcast to
discuss these results and provide a corporate update on Wednesday,
November 9, 2022, at 4:30 PM ET.
To participate in the call, please dial (877)-407-0784
(domestic) or (201)-689-8560 (international) and provide conference
ID: 13732861. The live webcast will be available on the IR Calendar
on the News/Events page of the Investors section of KORU Medical's
website.
Non-GAAP Measures
This press release includes the non-GAAP financial measures
"Adjusted EBITDA" and "Adjusted Diluted earnings per share" that
are not in accordance with, nor an alternate to, generally accepted
accounting principles and may be different from non-GAAP measures
used by other companies. These non-GAAP measures are not based on
any comprehensive set of accounting rules or principles. Non-GAAP
financial measures should not be considered a substitute for, or
superior to, measures of financial performance prepared in
accordance with GAAP. They are limited in value because they
exclude charges that have a material effect on KORU Medical's
reported results and, therefore, should not be relied upon as the
sole financial measures to evaluate the Company's financial
results. Non-GAAP financial measures are meant to supplement, and
to be viewed in conjunction with, GAAP financial results.
Reconciliations of the Company's non-GAAP measures are included at
the end of this press release.
About KORU Medical Systems
KORU Medical Systems develops, manufactures, and commercializes
innovative and easy-to-use subcutaneous drug delivery systems that
improve quality of life for patients around the world. The FREEDOM
Syringe Infusion System currently includes the FREEDOM60® and
FreedomEdge® Syringe Infusion Drivers, Precision Flow Rate Tubing™
and HIgH-Flo Subcutaneous Safety Needle Sets™. These devices are
used for infusions administered in the home and alternate care
settings. For more information, please visit
www.korumedical.com.
Forward-looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties. All statements that are not
historical fact are forward-looking statements, including, but not
limited to, expected financial outlook and operating performance
for fiscal 2022. Forward-looking statements discuss the Company's
current expectations and projections relating to its financial
position, results of operations, plans, objectives, future
performance and business. Forward-looking statements can be
identified by words such as "outlook", "expect", "plan", "believe"
and "will". Actual results may differ materially from the results
predicted and reported results should not be considered as an
indication of future performance. The potential risks and
uncertainties that could cause actual results to differ from the
results predicted include, among others, uncertainties associated
with the shift to increased healthcare delivery in the home, new
patient diagnoses, customer ordering patterns, COVID-19, innovation
and competition, labor and supply price increases, inflationary
impacts, labor supply, and those risks and uncertainties included
under the captions "Risk Factors" in our Annual Report on Form 10-K
for the year ended December 31, 2021 and our Quarterly Report on
Form 10-Q for the quarter ended June 30, 2022, which are on file
with the SEC and available on our website at
www.korumedical.com/investors and on the SEC website at
www.sec.gov. All information provided in this release and in the
attachments is as of November 9. Undue reliance should not be
placed on the forward-looking statements in this press release,
which are based on information available to us on the date hereof.
We undertake no duty to update this information unless required by
law.
KORU MEDICAL SYSTEMS,
INC.
BALANCE SHEETS
(UNAUDITED)
September 30,
December 31,
2022
2021
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
16,441,268
$
25,334,889
Accounts receivable less allowance for
doubtful accounts of $24,471 for September 30, 2022, and December
31, 2021
5,070,077
3,592,886
Inventory
6,884,156
6,106,338
Other Receivables
686,108
718,220
Prepaid expenses
1,660,655
1,568,821
TOTAL CURRENT ASSETS
30,742,264
37,321,154
Property and equipment, net
3,318,612
1,106,445
Intangible assets, net of accumulated
amortization of $310,011 and $263,729 at September 30, 2022 and
December 31, 2021, respectively
798,534
808,813
Operating lease right-of-use assets
3,865,370
95,553
Finance lease right-of-use, net of
accumulated depreciation of $23,671 at September 30, 2022
331,400
—
Deferred income tax assets, net
3,520,823
1,941,254
Other assets
88,772
19,812
TOTAL ASSETS
$
42,665,775
$
41,293,031
LIABILITIES AND STOCKHOLDERS'
EQUITY
CURRENT LIABILITIES
Accounts payable
$
1,365,610
$
1,227,533
Accrued expenses
2,568,746
2,709,704
Notes Payable
644,733
508,583
Other Liabilities
357,491
90,000
Accrued payroll and related taxes
824,047
160,603
Finance lease liability - current
64,467
—
Operating lease liability – current
342,399
95,553
TOTAL CURRENT LIABILITIES
6,167,493
4,791,976
Finance lease liability, net of current
portion
265,542
—
Operating lease liability, net of current
portion
3,741,015
—
TOTAL LIABILITIES
10,174,050
4,791,976
Commitments and contingencies (Refer to
Note 3)
STOCKHOLDERS' EQUITY
Common stock, $0.01 par value, 75,000,000
shares authorized, 48,657,023 and 48,044,162 shares issued
45,236,521 and 44,623,660 shares outstanding at September 30, 2022,
and December 31, 2021, respectively
486,570
480,441
Additional paid-in capital
43,443,201
40,774,245
Treasury stock, 3,420,502 shares at
September 30, 2022 and December 31, 2021, respectively, at cost
(3,843,562
)
(3,843,562
)
Retained deficit
(7,594,484
)
(910,069
)
TOTAL STOCKHOLDERS' EQUITY
32,491,725
36,501,055
TOTAL LIABILITIES AND STOCKHOLDERS'
EQUITY
$
42,665,775
$
41,293,031
KORU MEDICAL SYSTEMS,
INC.
STATEMENTS OF
OPERATIONS
(UNAUDITED)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2022
2021
2022
2021
NET SALES
$
7,760,398
$
6,040,544
$
20,551,356
$
16,999,669
Cost of goods sold
3,438,036
2,544,794
9,260,516
7,061,881
Gross Profit
4,322,362
3,495,750
11,290,840
9,937,788
OPERATING EXPENSES
Selling, general and administrative
4,825,349
3,901,830
15,846,584
12,980,604
Research and development
862,148
800,020
3,314,233
1,523,739
Depreciation and amortization
164,344
115,934
399,479
349,822
Total Operating Expenses
5,851,841
4,817,784
19,560,296
14,854,165
Net Operating Loss
(1,529,479
)
(1,322,034
)
(8,269,456
)
(4,916,377
)
Non-Operating Income/(Expense)
Loss on currency exchange
(10,057
)
(7,283
)
(38,897
)
(21,761
)
Gain on disposal of fixed assets, net
—
273
—
1,009
Interest income (expense), net
42,476
(2,838
)
44,579
16,883
TOTAL OTHER INCOME/(EXPENSE)
32,419
(9,848
)
5,682
(3,869
)
LOSS BEFORE INCOME TAXES
(1,497,060
)
(1,331,882
)
(8,263,774
)
(4,920,246
)
Income Tax Benefit
271,500
238,104
1,579,359
1,425,781
NET LOSS
$
(1,225,559
)
$
(1,093,778
)
$
(6,684,415
)
$
(3,494,465
)
NET LOSS PER SHARE
Basic
$
(0.03
)
$
(0.02
)
$
(0.15
)
$
(0.08
)
Diluted
$
(0.03
)
$
(0.02
)
$
(0.15
)
$
(0.08
)
WEIGHTED AVERAGE NUMBER OF COMMON SHARES
OUTSTANDING
Basic
45,038,181
44,322,335
44,877,366
44,510,021
Diluted
45,038,181
44,322,335
44,877,366
44,510,021
KORU MEDICAL SYSTEMS,
INC.
STATEMENTS OF CASH
FLOWS
(UNAUDITED)
For the Nine Months
Ended
September 30,
2022
2021
CASH FLOWS FROM OPERATING ACTIVITIES
Net Loss
$
(6,684,415
)
$
(3,494,465
)
Adjustments to reconcile net loss to net
cash used in operating activities:
Stock-based compensation expense
2,361,085
1,967,632
Depreciation and amortization
399,479
349,822
Deferred income taxes
(1,579,569
)
(1,440,060
)
Loss on disposal of fixed assets
—
(1,009
)
ROU landlord credit
218,044
—
Changes in operating assets and
liabilities:
Increase in accounts receivable
(1,445,079
)
(549,711
)
Increase in inventory
(777,818
)
(138,160
)
Increase in prepaid expenses and other
assets
(160,794
)
(529,039
)
Increase in other liabilities
267,491
—
Increase in accounts payable
138,077
760,493
Increase in accrued payroll and related
taxes
663,444
45,684
Decrease in accrued expenses
(140,958
)
(573,565
)
NET CASH USED IN OPERATING ACTIVITIES
(6,741,012
)
(3,602,378
)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property and equipment
(2,541,693
)
(301,720
)
Proceeds from disposal of property and
equipment
—
9,065
Purchases of intangible assets
(36,003
)
(25,838
)
NET CASH USED IN INVESTING ACTIVITIES
(2,577,696
)
(318,493
)
CASH FLOWS FROM FINANCING ACTIVITIES
Borrowings from indebtedness
644,733
924,389
Payment on indebtedness
(508,583)
(251,255)
Proceeds from issuance of equity
314,000
1,230,000
Common stock issuance as settlement for
litigation
—
938,094
Payments on finance lease liability
(25,062
)
(2,232
)
NET CASH PROVIDED BY FINANCING
ACTIVITIES
425,087
2,838,996
NET DECREASE IN CASH AND CASH
EQUIVALENTS
(8,893,621
)
(1,081,875
)
CASH AND CASH EQUIVALENTS, BEGINNING OF
PERIOD
25,334,889
27,315,286
CASH AND CASH EQUIVALENTS, END OF
PERIOD
$
16,441,268
$
26,233,411
Supplemental Information
Cash paid during the periods for:
Interest
$
15,700
$
6,194
Income Taxes
$
—
$
850
Schedule of Non-Cash Operating, Investing
and Financing Activities:
Issuance of common stock as
compensation
$
355,505
$
295,947
Issuance of common stock as settlement for
litigation
$
—
$
938,094
KORU MEDICAL SYSTEMS,
INC.
SUPPLEMENTAL
INFORMATION
(UNAUDITED)
The following table summarizes our net
sales for the three and nine months ended September 30, 2022 and
2021:
Three Months
Ended September 30,
Nine Months
Ended September 30,
2022
2021
2022
2021
Net Sales
Domestic
$
5,900,042
$
5,076,294
$
15,890,369
$
14,084,552
International
1,096,746
747,281
2,943,173
2,585,881
Novel Therapies
763,610
216,969
1,717,814
329,236
Total
$
7,760,398
$
6,040,544
$
20,551,356
$
16,999,669
KORU MEDICAL SYSTEMS,
INC.
SUPPLEMENTAL
INFORMATION
(UNAUDITED)
A reconciliation of our non-GAAP measures
is below:
Three Months Ended
Nine Months Ended
Reconciliation of GAAP Net
(Loss)
September 30,
September 30,
to Non-GAAP Adjusted EBITDA:
2022
2021
2022
2021
GAAP Net Loss
$
(1,225,559
)
(1,093,778)
$
(6,684,415
)
$
(3,494,465
)
Tax (Benefit)/Expense
(271,500
)
(238,104)
(1,579,359
)
(1,425,781
)
Depreciation and Amortization
164,344
115,934
399,479
349,822
Interest (Income)/Expense, Net
(42,476)
2,838
(44,579)
(16,883
)
Reorganization Charges
200,000
(1,262)
765,433
1,192,618
Manufacturing Initiative Expenses
20,537
35,892
108,886
237,333
Stock-based Compensation Expense
779,510
628,276
2,429,999
1,967,632
Non-GAAP Adjusted EBITDA
$
(375,144
)
$
(556,204)
$
(4,604,556
)
$
(1,189,724)
Three Months Ended
Nine Months Ended
Reconciliation of Reported Diluted
EPS
September 30,
September 30,
to Non-GAAP Adjusted Diluted
EPS:
2022
2021
2022
2021
Reported Diluted Earnings Per Share
$
(0.03
)
$
(0.02
)
$
(0.15
)
$
(0.08
)
Reorganization Charges
—
—
0.02
0.03
Manufacturing Initiative Expenses
—
—
—
0.01
Stock-based Compensation Expense
—
—
—
0.01
Tax (Expense) Adjustment
—
—
—
(0.01
)
Non-GAAP Adjusted Diluted Earnings Per
Share
$
(0.03
)
$
(0.02)
$
(0.13
)
$
(0.04
)
Reorganization Charges. We have excluded the effect of
reorganization charges in calculating our non-GAAP measures. In
2021 we incurred significant expenses in connection with the
departure and replacement of our chief executive officer and the
recruiting of two new board members, which we would not have
otherwise incurred in periods presented as part of our continuing
operations. In 2022 we incurred further severance expense related
to the reorganization of the leadership team and the departure of
our chief financial officer, which we would not have otherwise
incurred in periods presented as part of continuing operations.
Manufacturing Initiative Expenses. We have excluded the effect
of expenses related to creating manufacturing efficiencies, in
calculating our non-GAAP measures. We incurred expenses in
connection with these initiatives which we would not have otherwise
incurred in periods presented as part of our continuing operations.
We expect to incur related expenses for the next three to six
months.
Stock-based Compensation Expense. We have excluded the effect of
stock-based compensation expense in calculating our non-GAAP
measures. We record non-cash compensation expense related to grants
of options and restricted shares for executives, employees and
consultants, and grants of shares to our board of directors.
Depending upon the size, timing and the terms of the grants, the
non-cash compensation expense may vary significantly but will recur
in future periods.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221109005855/en/
Greg Chodaczek 347-620-7010
investor@korumedical.com
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